Pregnancy Outcomes Following Ocrelizumab Treatment in Patients with Multiple Sclerosis and Other Autoimmune Diseases
Ocrelizumab, a humanized monoclonal antibody that selectively targets CD20+ B cells, has been studied as a treatment in clinical trials of multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
To review pregnancy outcomes in women treated with ocrelizumab.
This analysis included ocrelizumab-exposed women in clinical trials of MS, RA or SLE. Ocrelizumab doses ranged from 20 to 2000 mg. Across trials, women of childbearing potential were required to use two methods of contraception and continue contraception for 1 year/48 weeks after the last ocrelizumab infusion or until B cells repleted, whichever was longer. Urine pregnancy tests were performed at all infusion visits; if positive, dosing was stopped and the result was confirmed with a serum pregnancy test. An embryo/fetus was considered exposed to ocrelizumab in utero if the last infusion occurred within 3 months of conception or during pregnancy or if the date was unknown. All pregnancies occurring during the studies were to be followed to determine outcome.
From 2008 to September 14, 2015, 46 women (15 MS, 10 SLE, 21 RA) reported 48 pregnancies (15 MS, 11 SLE, 22 RA). Among the pregnancies in patients with MS, seven were considered to have fetal ocrelizumab exposure, including one pregnancy which progressed to a healthy term baby, four elective terminations and two ongoing pregnancies. Seven pregnancies had no fetal ocrelizumab exposure and resulted in two healthy term babies; one infant born preterm at 34 weeks’ gestation with nasopharyngeal neoplasm (histopathologic details unknown), jaundice, respiratory disease and low birth weight; two elective abortions; and two ongoing pregnancies. One pregnancy that was not assessable for fetal ocrelizumab exposure ended in elective termination. Additional pregnancy outcomes in autoimmune populations that are distinct from MS, including SLE and RA, will be reported.
Considering that a large proportion of patients with MS are women of reproductive age, pregnancy outcomes in patients exposed to ocrelizumab are important to understand. Hence, pregnancy outcomes in ongoing ocrelizumab studies will continue to be assessed and reported.